Bioabsorbable magnesium knots for securing surgical suture

Abstract

A crimpable magnesium sleeve for securing a suture within the body and for dissolving over time while introducing only compatible amounts of magnesium into the body. An instrument for placing such a sleeve on a suture crimping the sleeve and cutting the suture after placement. An alloy of magnesium, zinc, and aluminum may be used to form the sleeve.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]None.STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT[0002]None.NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT[0003]None.REFERENCE TO A “SEQUENCE LISTING”[0004]None.BACKGROUND OF THE INVENTION[0005]1. Field of the Invention[0006]This invention relates generally to crimpable metal sleeves used to remotely secure sutures, and more particularly to such sleeves made from magnesium and its alloys.[0007]2. Description of Related Art[0008]A surgeon's ability to hand tie a secure knot in a suture is severely compromised in many minimally invasive surgical procedures. When absorbable sutures are preferred at remote tissue sites, it would be a significant advance to be able to readily create a strong, safe, low profile absorbable knot.[0009]Less invasive therapeutic interventions are most beneficial when the desired physiological or surgical outcome can be achieved with the least amount of iatrogenic trauma to the patient. For ex...

AI Technical Summary

Benefits of technology

[0025]A significant clinical need exists for a means for providing a strong, low profile bioabsorbable knot for surgical suture left at some remote wound closure sites. The minimally invasive surgeon cannot simply hand tie knots in absorbable suture at remote sites as is easily achievable in open surgery. While crimped, non-absorbable titanium sleeves have proved highly effective at securing suture together, they remain permanently within the patient. Bioabsorbable polymeric materials have not proved strong or durable enough for reliable, low profile, easy deployment for this application. The present invention is a novel development utilizing biocompatible, malleable, strong and absorbable alloys of magnesium to effectively place an automated remote suture knot that does not remain forever as a permanent foreign material at the suture site.

[0028]In accordance with another aspect of the invention, the hammer and anvil structures in the distal tip of the Titanium Knot® crimper are modified to decrease the crimping depth and eliminate corners that concentrate stresses so that crimping between the hammer and anvil did not cause cracking of the Magnesium Knot.

[0031]These preferred embodiments have acceptable characteristics and positive results in table top testing and in human cadaver models and have lead to further testing in in-vivo porcine models. Using laparoscopic techniques, 41 Magnesium Knots were placed at varying tissue sites securing a variety of suture types in the abdominal cavities of three pigs. These knots were subsequently harvested at one, two and three week intervals post-op. Successful healing was demonstrated at gastric, urinary bladder and uterine tissue sites. Magnesium Knots, placed both from the inside and the outside of the urinary bladder, were also effective over this critical three week time interval in closing wounds in the bladder wall.

Problems solved by technology

Bioabsorbable polymeric materials have not proved strong or durable enough for reliable, low profile, easy deployment for this application.

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